A Randomized, Controlled Trial Comparing Wound COmplications in Elective Midline Laparotomies After FAscia Closure Using Two Different Techniques of Running Sutures: COFACTOR-trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Incisional hernia
研究概览
简要总结
Wound complications, increased hospital stays and post-operative morbidity are all common following abdominal surgery. Abdominal closure complications are strongly associated with the closure technique and material used. The traditional closure technique used by surgeons is placing the wide and large stitches. A randomized controlled trial done in Sweden described a new closure technique in surgeries by placing the stitches closer to each other by using narrow. The results showed lower incidence of wound infections, hernias, and wound rupture. However, the study provides low quality evidence on the benefits of this new technique since it has numerous limitations like lack of standardization of suture size, lack of proper randomization, and heterogeneity in patient eligibility which will increase result bias. There is still a need for quality evidence on the effectiveness of this new closing technique procedure at decreasing wound complications after the operation.
In this trial the investigators will compare two techniques in the closure of abdominal wounds in patients undergoing abdominal surgery. The first technique will be the traditional closure technique currently used in abdominal surgery. The second technique will be using the new closure technique. The closure of abdominal wounds with small and close sutures using the new technique is expected to lower the incidence of hernia and wound complications as well as improve the quality of life of the patient. Potential candidates for the study are those who will be undergoing elective midline laparotomy at AUBMC. The patients and assessor of outcomes will be blinded and patients will be randomized to receive either the traditional or new closure operation technique. There are no anticipated risks for those participating in the study. All data and information collected will be kept confidential.
Hypothesis:
Closure of abdominal fascia in elective midline laparotomy incisions with small and close sutures compared to closure with conventional wide and distant sutures results in lower rates of wound rupture, incisional hernia, and wound infection, and improved quality of life.
Significance:
The results of this study will allow surgeons to assess the role of a new abdominal closure technique in decreasing short and long term postoperative complications, for a commonly performed procedure. This trial will generate evidence-based conclusions.
详细描述
Trial Design:
This trial is designed as a 1:1 randomized, controlled, patient and assessor-blinded, parallel design, superiority trial, with a primary endpoint of incisional hernia at one year.
Study Settings:
The investigators will conduct the study at the American University of Beirut Medical Center, which is an academic, tertiary referral center.
Prior to conducting this trial, the investigators will conduct a pilot study to study the feasibility of implementing the final trial by assessing items related to the institutional systems, the trial itself, and study subjects. The pilot study will assess the patient's response rate to participate in the trial, acceptance of patients to be examined daily by the research team, adherence of patients to the scheduled postoperative visits especially the one year follow up visit, and the proportion of loss to follow up. In the pilot, the investigators will also study the reliability of the randomization and allocation concealment strategy, and success of blinding of the research team from treatment allocation, efficacy of the training session and procedure video, consistency of evaluation among different surgeons performing the outcome assessments, and availability of the study team for the scheduled evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Signed Informed Consent
- •Undergoing an elective laparotomy through a midline incision
- •Undergoing a midline laparoscopic procedure (midline laparoscopic extraction site)
排除标准
- •Emergency surgery
- •Laparotomy through an incision other than midline
- •Previous midline laparotomy
- •Presence of incisional or ventral hernia at time of laparotomy
- •Incisional hernia repair
- •Laparotomy surgery during pregnancy
结局指标
主要结局
Incisional hernia
时间窗: 1 year
We will define incisional hernia according to the European Society of Hernia: "any abdominal wall gap with or without bulge in the area of a postoperative scar perceptible or palpable by clinical examination or imaging". (7) Using both clinical exam and imaging if performed, these hernias will be described according to their location along the midline, size of the defect using vertical and transverse measurements, and reducibility of any protruding viscera upon lying down or following gentle pressure by the examining hand. Also, we will collect information whether the hernia is causing any pain, discomfort, decrease in mobility, or any incidence of incarceration where the hernia contents protrude and does not reduce to the abdomen upon gentle pressure.
次要结局
- Fascial dehiscence or evisceration(1 month postoperative)
- Intervention rate for wound complications(1 month postoperative)
研究者
Eman Sbaity
Instructor of Surgery
American University of Beirut Medical Center